You are here

TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

ADEC 242nd meeting resolutions, 6-7 October 2005

Australian Drug Evaluation Committee

6 October 2005

Published in the Commonwealth of Australia Gazette, No. GN 42, 26 October 2005

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 242nd (2005/5) meeting of the Australian Drug Evaluation Committee (ADEC) (6-7 October 2005) resolved to advise the Parliamentary Secretary to the Minister for Health and Ageing and the Secretary, Department of Health and Ageing that the following medicine should be approved for registration, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the Therapeutic Goods Administration. This recommendation for approval may be subject to specific conditions.

ALENDRONIC ACID 70mg AND CHOLECALCIFEROL 70µg
Fosamax Plus Once Weekly
Tablets
Merck Sharp & Dohme (Australia) Pty Limited
New fixed combination - The treatment of osteoporosis in select patients where vitamin D supplementation is recommended.

PEGVISOMANT 10mg, 15mg and 20mg
Somavert
Powder for Injection
Pfizer Australia Pty Ltd
New chemical entity - The treatment of acromegaly in patients who have had inadequate response to surgery and/or radiation and/or other medical therapies or for whom these therapies are not appropriate. The treatment goal is to normalise IGF-1 levels.

SODIUM VALPROATE 400 mg
Epilim IV
Powder for Injection
Sanofi-Synthelabo Pty Ltd
New dosage form and new route of administration - The treatment of patients with epilepsy or mania, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.

CLOSTRIDIUM BOTULINUM TYPE A TOXIN - 500 IPSEN units per vial
Dysport
Powder for Injection
Ipsen Australia Pty Ltd
Extension of indication - Treatment of moderate to severe glabellar lines in adults.

Top of page

PERTUSSIS VACCINE ACELLULAR COMBINED WITH DIPHTHERIA AND TETANUS TOXOIDS 0.5mL
Adacel
Suspension for Injection
Aventis Pasteur Pty Limited
New substance - Active immunisation against tetanus, diphtheria and pertussis in persons aged 10 years and over as a booster following primary immunisation.

LINEZOLID 2mg/mL, 400 & 600 mg, 20 mg /mL
Zyvox
Tablets, Injection and Granules for Oral Suspension
Pfizer Australia Pty Ltd
Extension of patient group - The treatment of suspected or proven infections due to gram positive organisms resistant to multiple classes of antibiotics, including methicillin resistant Staphylococcus and vancomycin resistant Enterococcus species.

COMBINED MEASLES, MUMPS, RUBELLA AND VARICELLA VACCINE 0.5 mL
Priorix-Tetra
Powder for injection
GlaxoSmithKline Australia Pty Ltd
New combination - Active immunisation against measles, mumps, rubella and varicella from 9 months of age.

Top of page

MENINGOCOCCAL GROUP C CONJUGATE VACCINE 0.5mL
Meningitec
Suspension for intramuscular injection
Wyeth Australia Pty Limited
Change to dosage regimen - For the prevention of invasive disease caused by Neisseria meningitidis serogroup C

OXYCODONE HYDROCHLORIDE 10mg/1mL and 20mg/2mL
Oxynorm
Ampoules for injection
Mundipharma Pty Ltd
New dose form - The management of opioid responsive, moderate to severe pain.

ADALIMUMAB 40mg
Humira
Solution for injection (vial and pre-filled syringe)
Abbott Australasia Pty Ltd
Extension of indication - The treatment of moderate to severely active psoriatic arthritis where response to previous DMARDS has been inadequate. Humira is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease.

ADALIMUMAB 40mg
Humira
Solution for injection (vial and prefilled syringe)
Abbott Australasia Pty Ltd
Extension of indication - Humira is indicated for reducing the signs and symptoms, inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. Humira can be used alone or in combination with methotrexate.

GOSERELIN ACETATE 3.6 and 10.8 mg
Zoladex
Depot injection
AstraZeneca Pty Ltd
Extension of indications - For the management of locally advanced prostate cancer in men suitable for hormone manipulation.

EPOETIN BETA RCH 4,000U/0.3 mL, 6,000 U/0.3 mL, 20,000U/0.6 mL and
30,000U/0.6 mL
Neorecormon
Solution for injection
Roche Products Pty Limited
Extension of indications and changes to trade name, strength, dosages and Product Information - Treatment of anaemia and reduction of transfusion requirements in patients with non-myeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy.

1 December 2005

Top of page